Spots Global Cancer Trial Database for Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients
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Trial Identification
Brief Title: Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients
Official Title: Multicentre, Randomised, Phase 2 Trial of Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (Metastatic Osteosarcoma at Diagnosis or Localised Disease With Poor Histological Response)
Study ID: NCT03643133
Conditions
Study Description
Brief Summary: Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response).
Detailed Description: Multicentre, randomised, open-label, phase II trial, with 2 parallel groups. After pre-operative chemotherapy and surgery of the primary tumour and lung metastases (if applicable), patients presenting high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response) will be randomised between 2 arms: * Control arm: post-operative chemotherapy alone (with regimens adapted to the age of patient) * Experimental arm : post-operative chemotherapy combined with mifamurtide This randomised trial is part of a study recruiting all patients ≤50 years old with a newly diagnosed high-grade osteosarcoma.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU Amiens-Picardie - Service d'oncologie hématologie pédiatrique, Amiens, , France
CHU d'Angers - Service d'oncologie pédiatrique, Angers, , France
Institut Bergonié - Service d'oncologie médicale, Bordeaux, , France
CHU de Caen - Service d'oncologie hématologie pédiatrique, Caen, , France
CHU de Grenoble - Service d'oncologie hématologie pédiatrique, La Tronche, , France
Centre Oscar Lambret - Unité d'onco-pédiatrie, Lille, , France
Centre Léon Bérard - IHOPE, Lyon, , France
Centre Léon Bérard - Service d'oncologie médicale, Lyon, , France
Hôpital de la Timone - service d'oncologie médicale, Marseille, , France
Hôpital de la Timone - Service d'oncologie pédiatrique, Marseille, , France
CHU Arnaud de Villeneuve - Onco-hématologie pédiatrique, Montpellier, , France
Institut régional du Cancer de Montpellier - Service d'oncologie médicale, Montpellier, , France
CHU de Nantes - Service d'oncologie hématologie pédiatrique, Nantes, , France
CHU de Nice - Service d'oncologie hématologie pédiatrique, Nice, , France
Institut Curie - Service d'oncologie médicale, Paris, , France
Hôpital Armand Trousseau - Service d'hématologie et d'oncologie pédiatrique, Paris, , France
Hôpital Cochin, Paris, , France
Institut Curie - Service d'oncologie pédiatrique, Paris, , France
Centre Eugène Marquis - Service d'oncologie médicale, Rennes, , France
Hôpital Charles Nicolle - Hémato-Immuno-Oncologie Pédiatrique, Rouen, , France
Institut de Cancérologie de l'Ouest (Site René Gauducheau) - Service d'oncologie médicale, Saint-Herblain, , France
Hôpital de Hautepierre - Onco-hématologie adulte, Strasbourg, , France
Hôpital Hautepierre - Onco-hématologie pédiatrique, Strasbourg, , France
CHU Toulouse - Hôpital des Enfants - Service d'Hémato-Immuno-Oncologie, Toulouse, , France
Institut Claudius Regaud - service d'oncologie médicale, Toulouse, , France
CHU Bretonneau - Service d'oncologie médicale, Tours, , France
Hôpital Clocheville - Hématologie et oncologie pédiatrique, Tours, , France
CHRU de Nancy - Onco-hématologie pédiatrique, Vandœuvre-lès-Nancy, , France
Institut de Cancérologie de Lorraine - Service d'oncologie médicale, Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy - Service de cancérologie de l'enfant et de l'adolescent, Villejuif, , France
Institut Gustave Roussy - Service d'oncologie médicale, Villejuif, , France
Contact Details
Name: Nathalie MD GASPAR, PhD
Affiliation: Gustave Roussy Cancer Campus
Role: PRINCIPAL_INVESTIGATOR
Name: Sophie MD PIPERNO-NEUMANN, PhD
Affiliation: Institut Curie
Role: PRINCIPAL_INVESTIGATOR
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